This is a single dose clinical trial to assess the Pharmacokinetics of two (2) dosages; 10 mg and 20mg of THC: THCa of Prana P1 bionutrients in healthy volunteers.
Single oral dose, (10 mg Prana P1 or 20 mg Prana P1) in each period with a washout of 30 days between doses. Patents will be randomly assigned dose for the first round of the study after a thirty-day washout, patient will return to the study site and receive cross over dose. Metabolites to be Measured: 1. THC 2. 11-OH-THC \[primary secondary metabolite of THC, psychoactive\] 3. THC-COOH \[inactive metabolite\] The following parameters for THC, 11-OH-THC, and THC-COOH will be assessed: AUC0-t, AUC0-inf, Cmax, AUCt/inf, Tmax. Safety will be monitored and assessed through adverse events reports, 12-lead ECG, vital signs and laboratory parameters. Each participant will undergo a psychometric evaluation using the CHAT assessment tool.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
10 mg or 20 mg of THC:THCa
Tropical Metabolism Research Unit, Caribbean Institute for Health Reserach, University of the West Indies, Mona
Kingston, Jamaica
Peak Plasma Concentration( Cmax) of following a single dose of 10 mg Prana 1
Maximum plasma concentration of Prana P1 following a single dose of 10 mg of Prana P1 1. Pk endpoints of delta 9-tetrahydrocannabinol (THC) (0-24 hours post-dose) (Cmax) of THC. Pk endpoints of THC(0-48 hours post-dose) 2. PK endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (T- 0-24 hours post-dose) Mean Cmax of 11-OH-THC. Mean AUC(0-t)) of 11-OH-THC. 3. PK endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (Time: 0-24 hours post-dose) Mean Cmax of 11-COOH-THC.
Time frame: At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs
Peak Plasma Concentration( Cmax) of following a single dose of 20 mg Prana 1
Maximum plasma concentration of Prana P1 following a single dose of 20 mg of Prana P1 1. Pk endpoints of delta 9-tetrahydrocannabinol (THC) (0-24 hours post-dose) (Cmax) of THC. Pk endpoints of THC(0-48 hours post-dose) 2. PK endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (T- 0-24 hours post-dose) Mean Cmax of 11-OH-THC. Mean AUC(0-t)) of 11-OH-THC. 3. PK endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (Time: 0-24 hours post-dose) Mean Cmax of 11-COOH-THC.
Time frame: At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs
Number of participants with treatment related adverse events as assessed by CTCAE v 5.0
Number of participants who experience at least one adverse event during the treatment phase relative to the pre-treatment baseline, is presented. The number of participants with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline. (Time Frame: screening to follow-up 30 days) 5. The number of participants with a clinically significant change in vital signs, relative to pre-treatment baseline. From screening to follow-up of 30 days) 6.The number of participants with clinically significant changes in indices of the CHAT assessment tool.
Time frame: up to 30 days post dose
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Number of participants who discontinue treatment due to side effects
Number of participants who discontinue study drug due to adverse events during treatment .
Time frame: up to 30 days